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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned a (b)(6) female patient of (b)(6) nationality. Medical history included primary hypertension, diabetic nephropathy, left pituitary gland had tubercle and current pregnancy. Drug adverse reaction history and family drug adverse reaction were none. She used unspecified insulin for less than one month during pregnancy. Concomitant medication included metformin and probucol for unknown indication. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100 u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (16 units in morning and 14 units in night), subcutaneously, for the treatment of gestational diabetes mellitus beginning from (b)(6) 2017. The date of her last menstrual period and estimate due date (edd) were not provided. The manufacturer had estimated a due date of (b)(6) 2018. The mother began insulin lispro protamine suspension 50%/insulin lispro 50% at unknown weeks of pregnancy. On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she experienced high blood glucose for which she was hospitalized in (b)(6)2018. In (b)(6) 2018, humapen ergo ii could not be pushed down and the injection screw could not move ((b)(4)/ lot number 1611d02). Information regarding corrective treatment, hospitalization details and outcome for the events was not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing. The operator of the humapen ergo ii and his/ her training status were not provided. The humapen ergo ii model duration of use and suspect humapen ergo ii duration of use were not provided but it was started since (b)(6) 2017. The action taken with the suspect humapen ergo ii and its return status was not provided. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% and did not provide a relatedness assessment for the events to humapen ergo ii. The exposure event was captured for tracking purpose. Edit 25may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7566702
MDR Text Key110071246
Report Number1819470-2018-00099
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1611D02
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2018 Patient Sequence Number: 1
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